A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1994
History of Changes
To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients.
Drug : Netivudine
Drug : Acyclovir
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients are randomized to receive either 882C87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. They are stratified by presence or absence of HIV infection. Patients undergo 6 months of follow-up.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- Acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis.
- Immunocompromised condition primarily as a result of documented HIV infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy.
- Life expectancy of at least 6 months.
- Ability to cooperate with the requirements of the study.
- Evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes).
- Acute, life-threatening condition.
- Significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption.
- Intolerance of oral medication.
- Tricyclic antidepressants or anti-epileptics.
- Topical applications to the zoster lesions that would obscure evaluation.
- Fluorouracil and flucytosine.
- Systemic therapy with agents with antiherpetic activity (from 2 weeks prior to first dose to day 28 of study).
- Probenecid or other drugs likely to affect elimination of study drugs (from 2 days prior to first dose to day 14 of the study).
- Capsaicin (Zostrix).
- Warfarin (Coumadin) during 14 days of treatment.
- Systemic therapy with agents with antiherpetic activity (including interferon) within the past 2 weeks.
- Probenecid or other drugs likely to affect the elimination of 882C87 or acyclovir within the past 48 hours.
- Drugs likely to interact with 882C87 (e.g., fluorouracil or flucytosine) within the past 7 days.
- Zoster immune globulin or zoster immune plasma within the previous month. History of
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
History of intolerance, hypersensitivity, or severe drug reaction to acyclovir.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002315
Locations Show More
|United States, Alabama|
|Simon - Williamson Clinic|
|Birmingham, Alabama, United States, 35211|
|SORRA / NC Research Ctr|
|Birmingham, Alabama, United States, 35234|
|United States, Arizona|
|Univ of Arizona / Univ Med Ctr|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Cedars Sinai Med Ctr|
|Los Angeles, California, United States, 90048|
|AIDS Community Research Consortium|
|Redwood City, California, United States, 94063|
|Saint Francis Mem Hosp|
|San Francisco, California, United States, 94109|
|Sunnyvale Med Clinic|
|Sunnyvale, California, United States, 94086|
|United States, Connecticut|
|Clinical Research Consultants|
|Trumbull, Connecticut, United States, 06611|
|United States, Iowa|
|Med Associates Clinic|
|Dubuque, Iowa, United States, 52001|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70121|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, New Mexico|
|New Mexico Med Group|
|Albuquerque, New Mexico, United States, 87110|
|United States, North Carolina|
|Jordon Diagnostics and Research Inc|
|High Point, North Carolina, United States, 27262|
|Hanover Med Specialists|
|Wilmington, North Carolina, United States, 28401|
|United States, Oregon|
|Oregon Research Group|
|Eugene, Oregon, United States, 97401|
|Oregon Health Sciences Univ|
|Portland, Oregon, United States, 97201|
|United States, Rhode Island|
|Roger Williams Med Ctr|
|Providence, Rhode Island, United States, 02908|
|Silver Lake Med Inc|
|Providence, Rhode Island, United States, 02909|
|United States, Tennessee|
|Vanderbilt Med Ctr|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|N Texas Ctr for AIDS & Clin Rsch|
|Dallas, Texas, United States, 75219|
|MacGregor Med Association|
|Houston, Texas, United States, 77054|
|Univ TX Med Branch|
|Nassau Bay, Texas, United States, 77058|
|United States, Washington|
|Infections Ltd / Physicians Med Ctr|
|Tacoma, Washington, United States, 98405|
|United States, Wisconsin|
|Med Consultants LTD|
|Milwaukee, Wisconsin, United States, 53215|
|Rhinelander Med Ctr|
|Rhinelander, Wisconsin, United States, 54501|
Sponsors and CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov Identifier:||NCT00002315 History of Changes|
|Other Study ID Numbers:||130A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Herpes Zoster
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.